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Bupropion and Cigarette-Related Cues in Smokers

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ClinicalTrials.gov Identifier: NCT03920319
Recruitment Status : Completed
First Posted : April 18, 2019
Last Update Posted : April 18, 2019
Sponsor:
Information provided by (Responsible Party):
University of California, Los Angeles

Brief Summary:
Randomized, double-blind, before-after controlled trial to assess changes in regional brain activation in response to cigarette-related cues from before to after treatment with bupropion (vs placebo).

Condition or disease Intervention/treatment Phase
Smoking Smoking, Tobacco Drug: Bupropion Other: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, double-blind, before-after controlled trial
Masking: Double (Participant, Care Provider)
Masking Description: Matching placebo pills
Primary Purpose: Basic Science
Official Title: Effect of Bupropion Treatment on Brain Activation Induced by Cigarette-Related Cues in Smokers
Actual Study Start Date : January 1, 2004
Actual Primary Completion Date : December 31, 2005
Actual Study Completion Date : December 31, 2005

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Bupropion
Participants assigned to 150mg of bupropion daily for the first 3 days, followed by titration up to 2 pills daily, separated by 8 hours, for the remaining 8 weeks of treatment.
Drug: Bupropion
Bupropion 150 mg sustained release
Other Names:
  • bupropion HCl
  • Wellbutrin

Placebo Comparator: Placebo
Participants assigned to pill placebo daily for the first 3 days, followed by titration up to 2 pills daily, separated by 8 hours, for the remaining 8 weeks of treatment.
Other: Placebo



Primary Outcome Measures :
  1. Craving ratings [ Time Frame: 8 weeks ]
    Participants were instructed to respond from 1 (definitely not) to 5 (definitely) on the question, "I crave a cigarette right now", after viewing video cues.


Secondary Outcome Measures :
  1. Exhaled carbon monoxide (CO) [ Time Frame: 8 weeks ]
    Participants were asked to hold their breath for as long as possible, ideally 15 seconds, then to breathe out slowly into the mouthpiece of a CO monitor, aiming to empty the lungs completely.

  2. Cigarettes per day [ Time Frame: 8 weeks ]
    Self-reported number of cigarettes smoked daily during the past 7 days [??]

  3. Fagerström Test for Nicotine Dependence (FTND) [ Time Frame: 8 weeks ]
    The FTND contains six items that evaluate the quantity of cigarette consumption, the compulsion to use, and dependence. The yes/no items are scored from 0 to 1 and multiple-choice items are scored from 0 to 3. The items are summed to yield a total score of 0-10. The higher the total Fagerström score, the more intense is the patient's physical dependence on nicotine.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • Treatment-seeking cigarette smoker
  • Meet DSM-IV criteria for nicotine dependence
  • Negative result on urine test for drug use during screening

Exclusion Criteria:

  • History of any Axis I psychiatric diagnosis other than nicotine dependence
  • Medical conditions that might affect brain function
  • Current use of medications that could alter brain function
  • Pregnancy
  • Current illicit drug use other than occasional use of marijuana
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Responsible Party: University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT03920319    
Other Study ID Numbers: Brody011
First Posted: April 18, 2019    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Bupropion
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors